Melatonin and Reduction of the Radiation Dermatitis in Breast Cancer Patients

Phase 3

Recruiting

• Conditions: Radiation Dermatitis.; Acute radiodermatitis; L58.0

• Registration Number: IRCT20231218060453N1
• Lead Sponsor: Shahid Beheshti University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Women aged above 18 years old with breast cancer diagnosis (stage I-?)
Previous surgery (lumpectomy or mastectomy)
Completion of chemotherapy 4 weeks prior to study entry (if it was prescribed for the patient)
Radiotherapy regimen with fractionation daily dose of 2 Gy

Exclusion Criteria

Pregnancy
Breast-feeding
Serious functional disorders of the liver
Epilepsy
Diabetes mellitus type 1 or 2
Uncontrolled hypertension
Concurrent connective tissue disorders
History of chest radiation radiotherapy
History of asthma or severe allergic reactions
Blood coagulation disorders
Concurrent immunosuppressive treatments
Taking sedative or anticoagulant drugs at the same time
Sensitivity to melatonin

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiation dermatitis grade ?. Timepoint: Determination of the grade of radiation dermatitis through direct inspection by physician from the beginning of the study to two weeks after the last radiotherapy fraction weekly. Method of measurement: Based on the standard grading criteria of CTCAE (Common Toxicity Criteria for Adverse Events, version 4.03) for cancer clinical trials.